1. Field of Invention
This invention pertains to an improved packaging system and methods for using and manufacturing such a packaging system. The packaging system is for packaging a sterilizable item that allows aseptic introduction of a sterile item, particularly one that has been subjected to flash sterilization, into a sterile environment.
2. Description of the Related Art
During surgery, a sterile field is maintained for patient safety. All instruments and appliances entering the sterile field must be sterile. It is common practice to sterilize such instruments and appliances before the surgery and to introduce those instruments and appliances in a sterile manner. Various devices and methods are employed to maintain sterility during storage and introduction into the sterile field.
For example, U.S. Pat. No. 5,638,661, titled “Method and packaging system for packaging a sterilizable item,” discloses one such system. The packaging system for the sterilizable item includes a sterilizable flexible elongate tubular member that forms a pouch. The item to be sterilized is placed in the tubular member, or pouch, near the closed end. The tubular member is folded closed and the packaging system and item are sterilized. After sterilization, the item can be dispensed from the sterile tubular member and transferred onto a sterile field by a single non-scrubbed attendant while maintaining the sterility and integrity of the item and the field. The construction of the tubular member is such that it is susceptible to flashover when handling, thereby compromising the sterility of the item.
It is also desirable to be able to determine if the item has been sterilized. Various devices and methods are employed to indicate sterility to operating room personnel. For example, U.S. Pat. No. 4,358,015, titled “Pressure sensitive closure pouch with insertable sterilization indicator,” discloses a sterilizable pouch that has a strip of adhesive adjacent the mouth with a peelable release strip. The peelable release strip includes an indicator means for indicating its exposure to a predetermined sterilization condition. To use the pouch, an article is inserted within the pouch, the peelable release strip is removed from the adhesive and placed within the pouch next to the article, and the adhesive strip on one of the webs is brought into contact with the other web to close the mouth of the pouch. When the pouch is sterilized, the indicator means on the peelable release strip within the pouch changes appearance to indicate the attainment of the predetermined sterilization condition within the pouch. In such a system, the pouch must be opened and the peelable release strip removed from the pouch before determining if the article has been sterilized.
Another example is U.S. Pat. No. 7,718,433, titled “Packaging system for a sterilized article.” The pouch includes an integral internal sterilization indicator. The sterilizing agent sensitive substance can be an indicator ink printed as an ink line on the interior of the sterilization pouch below the cuff. The indicator becomes visible during aseptic delivery of the packaged article to provide a clear indication as to whether or not adequate conditions for sterilization have been achieved.